Protocol summary

Study aim
In Spite of The Many Problems That Divorced Women Have to deal with, (ART) is very Effective for The Continuation of Life. (ART) is a Transdiagnostic Protocol That, From The very Beginning, has Focused on The Commonality of Various Psychological Disorders in Children With Deficits in General Emotion Regulation Skills. According to The Mentioned Materials and the Importance of Maintaining The Family Center and Creating Intimate Relationships Between Couples, it is Necessary to Conduct a Research Aimed at The Effectiveness of Emotion Regulation Training on Impulsivity, Conflict Resolution Styles and self-esteem of Divorced Women in Zahedan City.
Design
The Clinical Trial has a Control Group and an Intervention Group, where 30 Participants are Selected Through a Simple Random Sampling Method and are Completely Randomly Divided into Two Groups of 15 People.
Settings and conduct
8-Session (ART) method, The Control Group does not Receive Training.
Participants/Inclusion and exclusion criteria
Criteria for Entering The Research 1) Be Part of Those Who Refer to The Welfare Department and Shahid Nouri Judicial Complex (Family Court) in Zahedan city. 2) Having Interest and Willingness to Cooperate in The Field of Research and Education. Exit Criteria In Case of Unwillingness to Continue Cooperation for any Reason, The Participants Have the Right not to Participate in the above Research.
Intervention groups
The Participants in the Intervention Group Received 8 Sessions on(ART) , Which is The independent Variable, and the Control Group did not Receive Training during this Period, and Finally, After the Training Period, to Examine the Effect of Training on the Dependent Variables (Impulsivity, Solving styles -Conflict and Self-worth) the Post-test Method is Used.
Main outcome variables
Reducing impulsiveness , teaching the correct way to resolve conflicts and increasing self-worth

General information

Reason for update
Acronym
ART
IRCT registration information
IRCT registration number: IRCT20221228056954N1
Registration date: 2023-01-25, 1401/11/05
Registration timing: retrospective

Last update: 2023-01-25, 1401/11/05
Update count: 0
Registration date
2023-01-25, 1401/11/05
Registrant information
Name
Mohammad Reza Sadeghi Motlagh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3328 2504
Email address
mr.sadeghimotlagh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-07-21, 1401/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Emotion Regulation Training on Impulsivity, Conflict Resolution Styles and Self-Esteem of Divorced Women in Zahedan City
Public title
The Effectiveness of Emotion Regulation Training on Impulsivity, Conflict Resolution Styles and Self-esteem
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Be Part of Those Who Refer to The Welfare Department and Shahid Nouri Judicial Complex (Family Court) in Zahedan City. Having Interest and Willingness to Cooperate in The Field of Research and Education.
Exclusion criteria:
Women Who are Not Divorced.
Age
From 16 years old to 46 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method is used for random allocation. In this way, 30 cards are prepared that are identical in appearance. The number 1 is written on 15 of them, which represents the intervention group, and the number 2, which represents the control group, is written on the other 15. Then one of the cards will be randomly given to each of the qualified people to enter the study and this process will be done until all the people are allocated. It should be noted that the participants are unaware of the nature of the numbers and the type of intervention.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
This Research is Done For the First Time and in Terms of Applicability, The Variables and The Statistical Method of The Research are New and New.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Working Group/Committee of Ethics in Research of Islamic Azad University - Zahedan Branch
Street address
Sistan and Baluchistan, Zahedan, University Street, Islamic Azad University Complex, Zahedan branch
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98135978
Approval date
2022-05-08, 1401/02/18
Ethics committee reference number
IR.IAU.ZAH.REC.1401.008

Health conditions studied

1

Description of health condition studied
The Effectiveness of Emotion Regulation Training on Impulsivity, Conflict Resolution Styles and Self-Esteem of Divorced Women in Zahedan City
ICD-10 code
F63.8
ICD-10 code description
Other impulse disorders

Primary outcomes

1

Description
Determining the Effect of Emotion Regulation Training on Impulsivity and its Components
Timepoint
Two Stages of Pre-test (Initial Stage of Sampling) - Post-test (End of Emotion Regulation Training)
Method of measurement
Through the Impulsivity Questionnaire of Barrett et al. (2004)

2

Description
Determining the Effect of Emotion Regulation Training on Conflict Resolution Styles and its Components
Timepoint
Two Stages of Pre-test (Initial Stage of Sampling) - Post-test (End of Emotion Regulation Training)
Method of measurement
Through the Questionnaire of Conflict Resolution Styles in Rahim Couples (1992)

3

Description
Determining the Effect of Emotion Regulation Training on Self-worth and its Components
Timepoint
Two Stages of Pre-test (Initial Stage of Sampling) - Post-test (End of Emotion Regulation Training)
Method of measurement
Through the Self-esteem Questionnaire of Kroker et al. (2003)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The Participants in The Intervention Group Consist of 15 People. During the Research, They Received 8 Sessions of Emotion Regulation Training, which is the Independent Variable, and Finally, after completing the Training Course, to Examine the Effect of Training on the Dependent Variables (impulsivity, conflict resolution and self-esteem) the post-test method is used.
Category
Behavior

2

Description
Control group: The Participants in the Clinical Trial do not Receive Extra Training. And in order to solve and Eliminate the bias in the research, they have no knowledge about the field of emotion regulation training.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
-Welfare Counseling and Psychological Services Center and Shahid Nouri Family Court
Full name of responsible person
Mohammad Reza Sadeghi Mutlaq
Street address
Zahedan Bagheri St
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813458952
Phone
+98 915 846 2044
Email
Mr.sadeghimotlagh@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Faculty of Medicine, Zahedan Unit
Street address
Address, Sistan and Baluchistan, Zahedan, University Street, Islamic Azad University Complex, Zahedan Branch
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98135978
Phone
+98 54 3344 1600
Email
university@iauzah.ac.ir
Web page address
https://zahedan.iau.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
No
Proportion provided by this source
1
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammed Reza Sadeghi Motlagh
Position
University student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Bagheri Street, Zahedan, Sistan and Baluchistan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9813667139
Phone
+98 54 3321 1098
Email
mr.sadeghimotlagh@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Azizullah Mujahid
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Zahedan - Baharan Hospital
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3337 2151
Email
public@zaums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammod Raza Sadeghi Motlagh
Position
University student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Bagheri Street, Zahedan, Sistan and Baluchistan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 915 846 2044
Email
mr.sadeghimotlagh@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Emotion regulation training is a meta-diagnostic protocol proposed by Barking Whitely in 2014, which includes seven steps: 1- Introducing the protocol to the participants 2- Teaching muscle relaxation and breathing 3- The importance of doing regular exercises 4- Awareness without judgment 5- acceptance and tolerance 6- loving self-support 7- analysis and analysis of emotion 8- change of emotion and from the very beginning it has focused on the commonalities of various psychological disorders in Abet with defects in general skills of emotion regulation and this protocol consists of 8 treatment sessions It is formed and also adapted from other approaches, which include: cognitive behavioral therapy, empathy-based approach, emotion-focused therapy, etc. In the above research, for the first time, the effectiveness of this approach was studied and investigated in divorced women. and the aim is to investigate the effectiveness of this protocol on aspects of impulsivity, conflict resolution and self-worth.
When the data will become available and for how long
The time period considered for the above research is in such a way that after selecting the sample through the pre-test and determining the intervention and control groups, the participants of the intervention group will be trained in the process of 8 weeks in 2-hour sessions per week conducted by the researcher. It is implemented, participation and after the end of the training course from both groups (control and intervention) a post-test is conducted to determine the impact and effectiveness of the emotion regulation protocol.
To whom data/document is available
1- The participants have the right to access the documentary data related to their own details and current status in the field of research. 2- The researcher is allowed to access the data and documents after the informed consent form has been completed by the participants in order to review and analyze the research data.
Under which criteria data/document could be used
1) The patient's consent form should be completed and attached. 2) The method of keeping the patient's secrets should be determined. 3) A written consent form has been designed to participate in the research, which is provided to the participants. Emotion regulation training is provided.
From where data/document is obtainable
1- Researcher 2- In addition to reviewing and approving the research plan and guidelines, the research ethics committee has the right to monitor the plans during and after implementation in terms of compliance with ethical considerations. The information and documents requested by the ethics committee for monitoring should be provided by the researchers to this committee.
What processes are involved for a request to access data/document
1- During and after the end of the research, the principle of confidentiality and privacy of individuals will be observed, and the researcher is responsible for observing the principle of confidentiality and maintaining the secrets of the subjects and taking appropriate measures to prevent its publication. And the personal information of the subjects will be used only in this research, and if it is necessary to publish the personal information of the participants, this should be done with their informed consent, and if the participants want to know the results of the studies related to the research plan, measures will be taken. Considered necessary, such as (message, email, etc.) 2- The manner of reporting the results of this research is such that it guarantees the observance of the material and moral rights of all persons related to the research, including the researcher himself, as well as the subjects and the institution supporting the research.
Comments
1- The results of the above research will be published honestly, accurately and completely. The results, whether negative or positive, as well as sources of funding, organizational affiliation, and conflict of interest - if any - will be fully disclosed. 2- At the end of the research, every person who has been studied as a subject has the right to be informed about the results of the study and to benefit from interventions or methods whose usefulness has been shown in that study.
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